Lilly Adds Label Warnings for Mental Drug Zyprexa

Eli Lilly added strong warnings to the label of Zyprexa, its best-selling medicine for schizophrenia, citing Zyprexa’s tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems.

For the first time, Zyprexa’s label now acknowledges that the drug
appears to cause high blood sugar more than other medicines for
schizophrenia and bipolar disorder, called atypical antipsychotics.

Lilly has previously argued that by those criteria Zyprexa could not be distinguished from its competitors.

The new label will also indicate that patients who take Zyprexa
continue to gain weight for as long as two years after starting
therapy. That contradicts some earlier public statements by Lilly that
weight gain on Zyprexa tends to plateau after a few months of use. One
in six patients who take Zyprexa will gain more than 33 pounds after
two years of use, the label says.

“Today’s communication is part of Lilly’s historical and ongoing
commitment to inform doctors and patients about updated prescribing
information,” said Dr. Sara Corya, Lilly’s global medical director, in
a statement. “Zyprexa is an important treatment option for patients.”

The new warnings may add to the controversy surrounding Zyprexa,
which is by far Lilly’s best-selling drug, with global sales of more
than $2.3 billion in the first half of this year and nearly 3 million
prescriptions in the United States alone. Lilly said it had made the
label changes as a part of continuing discussions with the Food and Drug Administration.

Lilly has asked the F.D.A. to allow it to begin marketing Zyprexa
for adolescents, despite clinical trial data showing that Zyprexa
causes weight gain and metabolic problems in teenagers that can be even
more severe than in adults.

In part because of heavy marketing by drug companies, atypical
antipsychotic medicines have become one of the biggest and
fastest-growing drug classes. Overall sales for the category are
projected at close to $13 billion this year, despite scant evidence
that the new drugs work any better than older generic anti-psychotic
medicines that cost just pennies a pill.

The label changes come 11 years after Lilly began selling Zyprexa
and more than 12 years after a large Lilly clinical trial first showed
that Zyprexa might have negative effects on weight and blood sugar.

Internal Lilly documents disclosed by The Times last December
indicated that Lilly was aware of Zyprexa’s tendency to cause weight
gain and blood sugar changes by the late 1990’s but played down the
drug’s risks because of fears that disclosing them might affect sales.
The documents also indicated Lilly had told its sales representatives
to encourage doctors to prescribe Zyprexa to people who do not have
schizophrenia or bipolar disorder, Zyprexa’s only approved uses.

Lilly said at the time of those disclosures that the drug’s risks were already reflected in the label.

Federal laws prohibit drug companies from so-called "off-label
marketing," although doctors may prescribe drugs for whatever use they
see fit.

Lilly has spent $1.2 billion since 2004 to settle lawsuits from 28,500 people who claimed they developed diabetes
or heart problems after taking the drug, though Lilly says that Zyprexa
has never been proven to cause diabetes. At least 1,200 more lawsuits
are still pending.

In 2004, the American Diabetes Association said that Zyprexa was
more likely to cause diabetes than other commonly prescribed
antipsychotic medicines, although the F.D.A. has never made a
distinction between Zyprexa and other drugs. Even now, Zyprexa’s label
does not say it causes diabetes more than the other medicines, only
high blood sugar.

In the United States, Zyprexa’s prescriptions and market share have
slid steadily for three years, although the revenues it produces for
Lilly have not fallen because Lilly has routinely pushed through price
increases on the medicine, which can cost $8,000 for a year’s supply of
a standard 20-milligram dose.